NCT03585153

Brief Summary

The overall goal of this research is to develop and validate standard operating procedures (SOP) to assess the human pancreas in individuals with type 1 diabetes (T1D) and other forms of diabetes using advanced, quantitative magnetic resonance imaging (MRI) approaches.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
299mo left

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2014Dec 2050

Study Start

First participant enrolled

February 19, 2014

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
10.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
22 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2050

Last Updated

October 31, 2025

Status Verified

October 1, 2025

Enrollment Period

14.8 years

First QC Date

June 18, 2018

Last Update Submit

October 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pancreas Volume Index

    Size of the pancreas determined by longitudinal MRI, normalized to subject weight

    up to 10 years

Secondary Outcomes (1)

  • MRI of pancreas - Apparent Diffusion Coefficient

    up to 10 years

Study Arms (4)

Individuals with stage 3 T1D

Individuals with overt stage 3 type 1 diabetes

Other: Non-contrast magnetic resonance imaging

Healthy control

Individuals without type 1 diabetes

Other: Non-contrast magnetic resonance imaging

Autoantibody positive

Individuals with early stage type 1 diabetes (stage 1, stage 2) who possess two or more type 1 diabetes-related autoantibodies

Other: Non-contrast magnetic resonance imaging

Monogenic diabetes

Individuals with monogenic diabetes

Other: Non-contrast magnetic resonance imaging

Interventions

subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas

Autoantibody positiveHealthy controlIndividuals with stage 3 T1DMonogenic diabetes

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Individuals with diabetes for this study may be referred by any pediatric or adult endocrinologists. Healthy controls are recruited via a passive recruitment process. A small subset of controls will travel to multiple study centers to have an MRI. In this study, the MRI scan will be used for research purposes only. However, if we see something that is not normal, the participant will be told and asked to consult his or her doctor.

You may qualify if:

  • Subjects at least 8 years of age
  • Subjects with T1D must be imaged within 100 days of their date of diagnosis
  • Subjects must be able to read and provide assent/informed written consent

You may not qualify if:

  • Subjects with pancreatitis, cystic fibrosis, pancreatic adenocarcinoma, or neuroendocrine tumors
  • Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means because such devices may be displaced or malfunction
  • Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
  • Subjects who are pregnant or breast-feeding. Urine pregnancy test will be performed on women of child bearing potential who are not practicing appropriate contraception measures or menstruating.
  • Subjects who exhibit significant anxiety and/or claustrophobia
  • Subjects incapable of giving assent/informed written consent
  • For controls: subjects who have first degree relatives with T1D

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Colorado, Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

University of Chicago, Kovler Diabetes Center

Chicago, Illinois, 60637, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

University of Texas at Austin, Dell Medical School

Austin, Texas, 78712, United States

Location

St. Vincent's Institute of Medical Research

Melbourne, Victoria, Australia

Location

Related Publications (3)

  • Virostko J, Williams J, Hilmes M, Bowman C, Wright JJ, Du L, Kang H, Russell WE, Powers AC, Moore DJ. Pancreas Volume Declines During the First Year After Diagnosis of Type 1 Diabetes and Exhibits Altered Diffusion at Disease Onset. Diabetes Care. 2019 Feb;42(2):248-257. doi: 10.2337/dc18-1507. Epub 2018 Dec 14.

  • Williams JM, Hilmes MA, Archer B, Dulaney A, Du L, Kang H, Russell WE, Powers AC, Moore DJ, Virostko J. Repeatability and Reproducibility of Pancreas Volume Measurements Using MRI. Sci Rep. 2020 Mar 16;10(1):4767. doi: 10.1038/s41598-020-61759-9.

  • Wright JJ, Dulaney A, Williams JM, Hilmes MA, Du L, Kang H, Powers AC, Moore DJ, Virostko J. Longitudinal MRI Shows Progressive Decline in Pancreas Size and Altered Pancreas Shape in Type 1 Diabetes. J Clin Endocrinol Metab. 2023 Sep 18;108(10):2699-2707. doi: 10.1210/clinem/dgad150.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood; mouth saliva swab; urine

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Alvin C. Powers, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 12, 2018

Study Start

February 19, 2014

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2050

Last Updated

October 31, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations